SUPPLY CHAIN ARTICLES
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How Can We Move RNA Forward In Our Therapeutics Arsenal?
RNA technologies, including mRNA therapeutics, have emerged as a promising drug modality. However, they have unique challenges. BioPhorum has dedicated a team to investigate these challenges and this Q&A shares their practical considerations for how to move this field forward.
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A "Hot Take" on Personalized mRNA Medicines
mRNA’s small-scale and cell-free production are often-touted benefits in the personalized medicines sphere. But as I reviewed my notes from the BioPhorum ATMP member event, I found myself coming face to face with a difficult truth.
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ARW's ATMP Manufacturing Must-Reads (ST. PATRICK'S DAY EDITION!)
Day-in and day-out, I write, read, listen to, and watch as much content as I can about CGT and RNA therapy manufacturing, in particular, and/or other ATMP industry-related topics that you should at least be aware of in the manufacturing facility. Once a month, I compile the articles and industry updates I think are most worthy of your time into an unconventional roundup article.
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Innovations In The Oligonucleotide Supply Chain: Regulatory Considerations For Materials, Manufacturing, And Lifecycle Control
Oligonucleotide therapeutics have rapidly advanced into late-stage and commercial development, shifting regulatory focus toward the maturity of manufacturing and supply chain control rather than therapeutic novelty. Regulatory success now depends on how effectively sponsors translate innovative chemistries into well-characterized, scalable, and sustainable materials and processes.
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Assessing Quality Of mRNA Vaccines: Key Considerations
To address the need for standards for mRNA vaccines, the United States Pharmacopeia (USP) has convened vaccine experts to identify important quality attributes and to propose test methods that can be used to assess mRNA vaccine products. This article shares those CQAs and analytical procedure tips.
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The mRNA Supply Chain Revolution: Materials, Methods, And Momentum
mRNA innovation now hinges as much on manufacturing materials as on molecular design, with novel inputs shaping performance, cost, and scalability. As these less-mature materials move rapidly into production, strategic material selection and supplier alignment are becoming critical to manufacturing resilience and long-term success.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Researchers demonstrate a delivery mechanism that is a simple and ready-to-use transfection reagent that leads to outstanding transfection efficiencies in known hard-to-transfect stem cells.
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As novel mRNA therapies are starting to enter clinical stages of development, Aldevron is providing critical support in a number of ways with specialized products and services.
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Cryopreservation should be integrated across the entire supply chain to ensure traceability, reduce risk at handoffs, and support consistent, scalable therapy development and delivery.
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Plasmids are crucial for CRISPR-Cas9 gene-editing technology, and their role in CRISPR is expected to evolve with ongoing research.
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Risk analysis and lane qualification show supply chains perform consistently, meeting regulatory expectations by demonstrating control, reducing variability, and ensuring reliable delivery.
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Precise enzyme selection in IVT reduces dsRNA byproducts and boosts capping efficiency. This ensures high-quality mRNA production while easing the burden of complex downstream purification processes.
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We aim to highlight that commercially available LNP reagent mix, GenVoy-ILM, is an accessible and easy-to-use LNP formulation that allows for rapid preclinical development of RNA vaccines.